September 26, 2017 1:00 AM ET

Pharmaceuticals

Company Overview of Breckenridge Pharmaceutical, Inc.

Company Overview

Breckenridge Pharmaceutical, Inc. engages in the research, development, marketing, and distribution of generic prescription products in various therapeutic categories. The company markets its generic prescription products in various dosage forms, including tablets, capsules, soft gel capsules, liquids, suspensions, ophthalmics, nasal sprays, and powders, as well as focuses on the provision of injectables, transdermals, inhalers, and topicals. It also provides various medical foods for the dietary management of patients with therapeutic or chronic medical needs; and prenatal and dietary supplements. In addition, the company handles various aspects of business operations, including procurement...

6111 Broken Sound Parkway NW

Suite 170

Boca Raton, FL 33487

United States

Founded in 1983

Phone:

561-443-3314

Fax:

561-989-9747

Key Executives for Breckenridge Pharmaceutical, Inc.

Executive Director of Operations
Senior Vice President of Sales & Marketing-New Jersey Office
Vice President of Finance for CT Office
Associate Director of Technical Services for CT Office
Compensation as of Fiscal Year 2017.

Breckenridge Pharmaceutical, Inc. Key Developments

Breckenridge Pharmaceutical, Inc. Receives U.S. Food and Drug Administration Final Approval for Omeprazole Delayed-Release Capsules

Breckenridge Pharmaceutical, Inc. announced that it has received U.S. Food and Drug Administration final approval of its abbreviated new drug application (ANDA) for Omeprazole delayed-release capsules, USP, in 10mg, 20mg, 40mg strengths (AB rated to Prilosec®), which will be manufactured and supplied by its parent company, Laboratorios Dr. Esteve, S.A. (Barcelona, Spain). This ANDA is part of Breckenridge's growing portfolio of vertically-integrated products with Esteve, with the product's API manufactured by Esteve's API division, Esteve Quimica. Launch plans currently are underway. Omeprazole Delayed-release Capsules is a proton pump inhibitor (PPI) used to treat certain stomach and esophagus issues such as GERD and ulcers.

Breckenridge Pharmaceutical, Inc. Enters into Multi-Product Agreement with Sam Chun Dang Pharm. Co., Ltd

Breckenridge Pharmaceutical Inc. announced launch of multi-product agreement with Sam Chun Dang Pharm Co Ltd. (SCD), based in Seoul, Korea. As part of the agreement, Breckenridge and SCD expect to develop and commercialise at least seven ANDAs in South Korea for the US market. This agreement allows SCD to develop, manufacture and supply the products exclusively for Breckenridge for the US market, while Breckenridge will market and distribute the products in its label. Beginning in the first quarter of 2018, the partnership plans filing ANDAs for at least six ophthalmic products and one otic product. The total addressable IMS market value for this portfolio is USD 2.4 billion. This selection of products contributes to Breckenridge's Paragraph IV portfolio.

Breckenridge Pharmaceutical, Inc. Announces Final ANDA Approval for Azacitidine for Injection (Vidaza®)

Breckenridge Pharmaceutical, Inc. announced that FDA has granted final approval of its ANDA Azacitidine for Injection, 100mg per vial, Single-Dose Vial, a generic version of Vidaza® by Celgene Corporation.   Breckenridge submitted the ANDA with its development and manufacturing partner Natco Pharma Limited.  Breckenridge and Natco intend to launch its ANDA in the near future. Vidaza® is a prescription anti-cancer chemotherapy drug that is indicated to treat myelodysplastic syndrome (MDS). Vidaza® generated total combined sales of $188 million for the twelve-month period ending April, 2017, based on industry sales data.

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